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Dietary tweak may lower Crohn's risk in family members

NCT ID NCT05211518

Prevention Sponsor: Shaare Zedek Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a diet that avoids certain inflammatory foods could lower the risk of developing Crohn's disease in healthy people who have a close relative with the condition. Twenty-nine participants followed the 'Tasty & Healthy' diet for 8 weeks. The main goal was to see if levels of a gut inflammation marker (fecal calprotectin) would drop, suggesting a lower risk of future disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tasty & Healthy dietary intervention (excludes pro-inflammatory foods)
What this could lead to
If it works, this diet could help prevent Crohn's disease in people with a family history.
What could go wrong
This is a very small, early study with only 29 participants. The diet may not actually prevent disease, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

May 2021

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 38 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)\>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD. * Younger than 39 years of age, in order to maximize future risk of developing CD. * No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are \>70μg/g. Exclusion Criteria: * Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis * The use of antibiotics in the preceding month * Prior intestinal resection * Pregnancy (and up until six months after giving birth) * Celiac disease or Diabetes * Weight loss or weight gain by more than 20% body weight in the last 3 months * Extraintestinal manifestations (Arthritis/arthralgia, iritis/uveitis, skin/mouth lesions, peri-anal disease, Other fistula). * Underweight (children \<3th BMI percentile, adult above the age of 18 years: BMI\<18.5 kg/m2).

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease Crohn disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel diseases

Contacts and locations

Locations

  • Shaare Zedek Medical Center

    Jerusalem, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.